Reliance Life Sciences Private Limited: Azacitidine For Injection 100mg/vial, 1

Azacitidine for Injection 100mg/Vial manufactured by Reliance Life Sciences for Somerset Therapeutics is being recalled nationwide because it may not meet sterility standards, meaning it could potentially be contaminated. The recall affects all states in the U.S. and applies to the product with NDC 70069-0857-01. This is a Class II recall, indicating a serious health hazard, though the contamination risk is not certain.

Recalling firm
Reliance Life Sciences Private Limited
Product
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
Reason
Lack of Sterility Assurance
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-06-24
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/eab46185-42c2-4a33-a4b8-c1a46cb656fc